A Study of Dimdazenil in Patients With Parkinson's Disease and Insomnia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Soochow University
About this trial
This study will use sleep parameters measured by polysomnography (PSG) as the primary means to evaluate the efficacy and safety of dimdazenil, a GABAA receptor partial agonist, in treating insomnia in Parkinson's disease patients.
Eligibility criteria
Qualifiers
Provide written informed consent voluntarily after full comprehension of the study.
Be aged ≥18 years, male or female.
Meet the diagnostic criteria for Parkinson's disease according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition), with a modified Hoehn-Yahr stage ≤3.
Have insomnia symptoms [reduced total sleep time (<6.5 h) and/or sleep-onset latency >30 min, and/or ≥2 nocturnal awakenings, early-morning awakening, or poor sleep quality], occurring at least three times per week, accompanied by daytime dysfunction or daytime distress, with adequate opportunity for sleep yet difficulty initiating or maintaining sleep, and that cannot be fully explained by another sleep-wake disorder; and have satisfactory control of Parkinson's disease motor symptoms [MDS-UPDRS Part III (ON state) score ≤30].
Disqualifiers
Have Parkinson-plus syndromes, secondary parkinsonism, or other non-idiopathic Parkinson's disease.
Have used benzodiazepine sedative-hypnotics within 7 days prior to enrollment.
Have other significant comorbidities, such as malignant tumors, or clinically significant impairment of cardiac, hepatic, or renal function.
Have severe obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), respiratory insufficiency, or myasthenia gravis.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
50 Participants
are grouped into 1 trial groupLocations
Sponsors and collaborators
Second Affiliated Hospital of Soochow University
Lead sponsor
The Fourth Affiliated Hospital of Soochow University
Collaborator
Changshu Hospital of Traditional Chinese Medicine
Collaborator
The Second Affiliated Hospital of Jiaxing University
Collaborator
Source ClinicalTrials.gov